Approvable Letter Research Articles

Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014-2018) Using RE-AIM.

Background: Risk Evaluation and Mitigation Strategies (REMS) are safety programs that U.S. Food and Drug Administration can require to ensure a drug's benefits outweigh its risks and can be considered public health interventions. FDA's 2019 draft Guidance for Industry on REMS Assessments encourages the development of “novel methods for assessing REMS [to] help advance the science of post-market assessment of effectiveness of risk mitigation strategies.”Objective: To characterize REMS assessment plans using RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and identify areas for advancing methods for evaluating REMS programs. RE-AIM was selected for its wide application evaluating the translation of scientific advances into practice for public health impact.Methods: A content analysis of REMS assessment plans (N = 18) and measures(n = 540) was conducted for REMS programs approved by FDA between 1/1/2014–12/31/2018. Eligibility criteria were: a new drug application or biologic license application, included FDA-mandated mitigation strategies called elements to assure safe use (ETASU), and represented a single product REMS program. Assessment plans were collected from publicly available regulatory approval letters from REMS@FDA website. Blinded reviewers categorized each REMS assessment measure to a RE-AIM dimension, adjudicated their application (average IRR 75%), and refined the adapted dimensions' definitions. Dimensions were also mapped to REMS Assessment guidance categories.Results: The median number of assessment measures per REMS assessment plan was 31 (IQR: 21–36). Frequency of measures per RE-AIM criteria per REMS program was: Reach (median = 2; IQR: 2–4); Effectiveness (median = 2.5; IQR:1–4); Adoption (median = 3.5; IQR: 2–5); Implementation (median = 18; IQR: 15–24); Maintenance (median = 0; IQR: 0–1). Adoption (among prescriber, health system agents of implementation) was more commonly assessed than Reach (population-attributable number of patients affected). Assessment of heterogeneity of Adoption and Reach was generally absent. Implementation assessment measures were most common among drugs requiring evidence of safe-use conditions before dispensing or administering the drug. Patient-level Effectiveness and Maintenance assessments were most common among drugs requiring patient monitoring.Discussion: Implementation science frameworks, such as RE-AIM, can be applied to characterize REMS assessment measures and identify opportunities for standardizing and strengthening their evaluation. Methods to measure Maintenance are needed to provide real-world evidence of REMS integration into the healthcare system.

Legacy of Lower Heritage That Has Certified in Nagari Aua Kuniang West Pasaman District

According to the provisions of Government Regulation Number 10 of 1961 in conjunction with Government Regulation Number 24 of 1997 concerning Land Registration, those entitled to receive inheritance are required to request the transfer of rights. In this case the transition is due to inheritance. In most parts of Nagari Aua Kuniang, West Pasaman District, many of the rights were transferred through inheritance, which was preceded by the making of a basis for the rights to the pusako randah land. Based on this background. West Pasaman Regency. The method of approach used in this research is empirical juridical, namely research conducted by paying attention to the legal norms that apply, then comparing it with the reality or facts that occur in the field. The results showed that the Process of Registration for Pusako Randah Land Rights in Nagari Aua Kuniang, West Pasaman Regency included fulfilling or submitting the required documents including submitting an application for first time registration, a statement of ownership of the plot of land which includes a physical statement of the plot of land , attached ranji (lineage), a statement from the Wali Nagari, a letter of approval from members of the clan and along with an identity in the form of an Identity Card. The cause of inheritance of pusako randah land in Nagari Aua Kuniang, West Pasaman Regency is because the heirs want to get legal certainty and guarantee legal protection against the pusako randah, on the other hand it occurs because it can be used as collateral for credit in the banking and also to avoid disputes over land the pusako randah. The process of transferring the certificate of ownership due to inheritance of the pusako randah land in Nagari Aua Kuniang, West Pasaman Regency was carried out after the legal incident occurred, the heirs could carry out the process by completing and providing the required documents.

An Epidemiologic Study of Cystic Fibrosis in the Gaza Strip

Objective: To determine the distribution, trend,, manifestations, prognosis and genetic determinants of cystic fibrosis (CF) diseases in the past ten years (2009-2019) in The Gaza strip (GS). Methods: Hospital based cross-sectional study and retrospective review of health care facilities records was conducted. This study was performed in all CF cases (150 cases) of five governorates of GS. The study population was one hundred and fifty CF cases, where 71% of them were males. Questionnaire and checklist were the tools of data collection about the personal, socio-demographic, health status of CF patients. In addition, Hemoglobin examination was obtained in all cases. Also Allele-specific PCR technique was employed to study eight CFTR mutation types for subgroup of CF cases (100 CF cases). The records of health care facilities which provide services to CF patients for the past ten years were reviewed retrospectively to determine the number of children who were diagnosed and confirmed as CF. Results: The average age of subjects was 70.6+44 months. About 93.3% of cases were of white colored skin. About one third of the population were from North Gaza, while 34.7% of them were from Gaza City, 22% of them were from Mid-zone, and 11.3% of them from South Governorates. about 88.7% of cases’ parents were first and second degree relatives. The results showed that the average of incidence of CF disease during the past ten years was 2.53 cases: 10,000 live births. Also the study showed increase in the prevalence of CF disease through the past ten years in GS, where the average of prevalence was 6.86 cases: 100,000 persons in 2009 and become 7.43 cases: 100,000 persons in 2019. About three quarter of CF cases were diagnosed during infantile period of their lives. Most of CF cases (91%) were diagnosed by both clinical manifestations and sweat tests. The most frequent respiratory manifestations among CF cases were recurrent chest infections, chronic cough with viscid sputum. While the most frequent gastrointestinal manifestations were recurrent gastroenteritis, abdominal colic and flatulence, and malabsorption. Also 86.7% of CF cases were anemic, where the average of hemoglobin among CF cases was 9.44+0.52 g/dl. The results of the study showed that the average of mortality rate due to CF among population under 15 years through the last ten years (2009-2019) was 0.52 case: 100,000 persons in population under 15 years. Allele-specific PCR technique was employed to study eight CFTR mutation types for the CF cases among subgroup of CF cases (100 CF cases). The results of mutation testing revealed that 62.5% of known mutation-CF cases have at least single allele of F508. Moreover 12.5% of known mutation-CF cases were of homo 3120+1kb CFTR mutation. Also 14.07% of known mutation-CF cases were of homo N1303k CFTR mutation, homo G85E CFTR mutation, and homo 3120del 18.6kb CFTR mutation equally. According to CFTR mutations about half of CF cases were belonging to class II CF. Conclusion: The incidence and prevalence rates of CF in the GS were around the rates of Caucasian Western Europe populations, where the average prevalence of CF disease through the last ten years in Gaza strip was 7.52 cases per 100,000 population. The average annual mortality rate among those less than 15 years was 0.52 case per 100,000. About two thirds of known mutation of CF cases have at least a single allele of DF508, which is considered of severe type of CFTR mutations. Also half of the cases belong to class II of CF disease (severe form of disease). Recommendations: the main recommendation of the current study was the importance of establishing a reliable diagnosis of CF using a properly conducted sweat test. In addition, diagnostic radiology, and laboratory facilities for sputum culture and pulmonary function tests are important for both the initial diagnosis and the diagnosis of complications. Funding Statement: This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors. Declaration of Interests: The authors declare no conflicts of interest regarding the publication of this paper. Ethics Approval Statement: An official letter of approval to conduct the study was obtained from the Palestinian MOH and Helsinki Committee in the GS. The researcher signed a contract with (CFFC) Laboratory for conducting the sweat tests and analysis of blood samples for CBC. Furthermore, the researcher signed a contract with the Islamic University of Gaza main laboratory for doing the molecular and genotype testing by PCR.

Психолінгвальні маркери ранніх дизфункційних схем у вчителів із високим ступенем трудоголізму

У статті відображено результати дослідження психолінгвальних маркерів ранніх дисфункційних схем у вчителів. Дослідження представлене у вигляді багатопланового дослідження із залученням регресійного аналізу, де ранні дисфункційні схеми, психологічне благополуччя, задоволення шлюбом слугують незалежними змінними, а трудоголізм – залежною змінною. Після отримання дозволу від Ради з етики наукових досліджень Східноєвропейського національного університету імені Лесі Українки 53 учителі загальноосвітніх шкіл Волинської області (Україна) взяли участь у дослідженні трудоголізму, серед них 50 жінок, 3 чоловіків, середній вік 46,47 (SD=10,17), стаж роботи 24,06 (SD=10,97). Опитувальник Янга YSQ – S3, шкала трудоголізму (Shkoler et al., 2018), шкала задоволеності шлюбом (Столін, Романова, Бутенко), шкала задоволення щоденною працею (Loi et al., 2009), шкала психологічного благополуччя (Ryff & Keyes, 1995) використовувалися для дослідження трудоголізму та його предикторів у вчителів. Результати засвідчили, що ранні дисфункційні схеми, психологічне благополуччя, задоволеність шлюбом сукупно слугують предикторами трудоголізму у вчителів. Водночас лише ранні дисфункційні схеми є незалежними значущими предикторами трудоголізму. Визначено психолінгвальні маркери ранніх дисфункційних схем, пов’язаних із трудоголізмом. Високорозвинений трудоголізм у вчителів пов’язаний із очікуванням на катастрофу, страхом покарання і негативізмом, уявленням про власну некомпетентність і невдачу, пошуком визнання й високих стандартів. Важливим прикладним висновком дослідження є можливість використання психолінгвістичних маркерів для визначення ранніх дисфункційних схем, пов’язаних із трудоголізмом у вчителів.
 Література
 References
 
 Онопченко І. В. Психологічна валідизація і культурна адаптація опитувальника “The Workaholism Facet-Based Scale” (WFBS) // Наукові записки Національного університету «Острозька академія». Серія «Психологія». 2019. Вип. 9. С. 107-117.
 Braslow, M. D., Guerrettaz, J., Arkin, R. M., & Oleson, K. C. (2012). Self-doubt. Social and Personality Psychology Compass, 6(6), 470-482.
 Clance, P. R., & Imes, S. A. (1978). The imposter phenomenon in high achieving women: Dynamics and therapeutic intervention. Psychotherapy: Theory, Research & Practice, 15(3), 241.
 Mir, I., & Kamal, A. (2018). Role of workaholism and self-concept in predicting impostor feelings among employees. Pakistan Journal of Psychological Research, 33(2), 413-427.
 Oates, W. E. (1971). Confessions of a workaholic: The facts about work addiction. World Publishing Company.
 Ryff, C. D., & Keyes, C. L. M. (1995). The structure of psychological well-being revisited. Journal of Personality and Social Psychology, 69(4), 719-727.
 Young, J. E. (1999). Cognitive therapy for personality disorders: A schema-focused approach. Professional Resource Press/Professional Resource Exchange.
 
 References (translated and transliterated)
 
 Onopchenko, I. (2019). Psykholohichna validyzatsiya i kulturna adaptatsiia opytuvalnyka The Workaholism Facet-Based Scale (WFBS). Naukovi Zapyski of the Ostroh Academy National University. Psychology Series, 9, 107-117.
 Braslow, M. D., Guerrettaz, J., Arkin, R. M., & Oleson, K. C. (2012). Self-doubt. Social and Personality Psychology Compass, 6(6), 470-482.
 Clance, P. R. & Imes, S. A. (1978). The imposter phenomenon in high achieving women: Dynamics and therapeutic intervention. Psychotherapy: Theory, Research & Practice, 15(3), 241.
 Mir, I. & Kamal, A. (2018). Role of workaholism and self-concept in predicting impostor feelings among employees. Pakistan Journal of Psychological Research, 33(2), 413-427.
 Oates, W. E. (1971). Confessions of a workaholic: The facts about work addiction. World Publishing Company.
 Ryff, C. D., & Keyes, C. L. M. (1995). The structure of psychological well-being revisited. Journal of Personality and Social Psychology, 69(4), 719-727.
 Young, J. E. (1999). Cognitive therapy for personality disorders: A schema-focused approach. Professional Resource Press/Professional Resource Exchange.

Clinical Development of Biologics Approved by the US Food and Drug Administration, 2003-2016.

Biological therapies are increasingly common in the United States. Although their clinical development may deviate significantly from the classic paradigm used for small molecule drugs, there has been little systematic analysis of these programs. We describe the development programs and factors associated with approval in the first review cycle for biologics approved by the US Food and Drug Administration's Center for Drug Evaluation and Research (FDA CDER) between 2003 and 2016. We conducted a retrospective analysis of publicly available approval packages including clinical pharmacology/biopharmaceutics, medical and summary reviews, and approval letters for biologics approved by FDA CDER. We evaluated characteristics of the development program (eg, use of expedited pathways, clinical pharmacology studies, number and type of pivotal trials) and the prevalence and correlates of first cycle approval, a key indicator of successful product development. We assessed 81 development programs for 75 unique therapies. Most programs (67%) made use of at least 1 expedited designation and about half (49%) were designated as orphan products. The clinical pharmacology programs were highly variable and one in four (25%) did not include an ascending dose study, where the tolerability of the therapeutic is typically determined before pivotal trials. Since 2003, an increasing proportion of biologics have been approved on first cycle approval and with fewer than 2 pivotal clinical trials (P < .001 for trend). Of the approximately three-fourths (76%) of products that were approved on the first review cycle, the likelihood of such approval was greater among development programs that performed an ascending dose study (84% vs 55%, P = .01) or held an End of Phase 2 meeting (85% vs 57%, P = .01). Considerable regulatory flexibility, with respect to the number of pivotal trials and data supporting dosing, coincides with a growing number of biologics approved on an annual basis.

National Examination Misconduct: Magnitude and Perceived Determinants in Secondary and Preparatory Schools of Bale and West Arsi Zones

The main objective of this research was to assess experiences of teachers on national examination cheating encounter and its perceived predictors. We employed Institution based cross-sectional design which was supplemented by qualitative data to address the research objectives. Data was collected from 488 teachers via pretested questionnaire besides, interview and focus group discussion guides which were held with key informants. Before starting data collection process ethical approval letter was obtained from research ethical approval committee. Likewise, verbal consent was obtained from study participants and their confidentiality was kept as the received data used only for research purpose. To address the first objective pie chart was used while multivariate binary logistic regression was computed for the second objective this was via using SPSS version 21. For qualitative data, thematic analysis was done and finally the two data were merged together. The results reveled that about 346 (70.9%) of the study participants were reported as they came across national examination cheating during 2014 and 2015 academic years. Perception of teachers with regard to absence of conducive examination room (AOR= .119, 95%CI= (.039, .37)), presence of social linkage (AOR= .27, 95%CI (.12, .615)), poor examination supervision (P-value= 0.05)), parental pressure (AOR= 3.49, 95%CI (.1.16, 10.54) were predispose for national examination cheating. Furthermore, the qualitative result suggested many more determinants in addition to the above findings. Finally, the findings suggested that Provision of optimum finance for examination bodies and availing sufficient logistics like transportation facility is very critical and strong supervision system should be established by zonal and district educational offices. Keywords: Ethiopia, national examination cheating, magnitude, determinants DOI : 10.7176/JEP/10-31-02 Publication date: November 30 th 2019

ANALISIS PENERBITAN LAPORAN SURVEYOR PADA EKSPOR KONDENSAT MT. NEW ADVANCE DI HUSKY AREA MADURA STRAIT MARINE TERMINAL

ABSTRAKPerusahaan Husky-CNOOC Madura Limited (HCML) adalah wakil dari Pemerintah RepublikIndonesia untuk menjalankan kegiatan eksplorasi dan eksploitasi minyak dan gas bumi termasukkondensat di Blok Madura Strait. Kondensat akan disalurkan kepada pembeli domestik danmancanegara. Faktor yang mempengaruhi kelancaran ekspor di HCML adalah kelengkapandokumen-dokumen Pemberitahuan Ekspor Barang (PEB) berupa laporan surveyor (LS). Apabila LStidak terbit maka kuota perusahaan tidak terpenuhi seperti yang telah direncanakan. Penelitian inibertujuan untuk mengetahui alur, kendala, dan upaya yang dilakukan dalam penerbitan laporansurveyor pada ekspor kondensat MT. New Advance di Husky Area Madura Strait Marine Terminal.Penulis menggunakan metode deskriptif kualitatif dengan menjelaskan data secara rinciberdasarkan fakta yang ada. Untuk metode pengumpulan data, penulis melakukan observasi,wawancara, dokumentasi, serta studi kepustakaan.Untuk menerbitkan laporan surveyor terdapat beberapa tahapan yang harus dilakukandisertai kelengkapan dokumen pendukung seperti Surat Persetujuan Ekspor (SPE). Padapelaksanaan ekspor kondensat MT. New Advance ditemukan kendala dalam penerbitan laporansurveyor dikarenakan SPE telah kadaluwarsa dan cuaca buruk di Madura Strait Marine Terminal.Upaya yang dilakukan untuk mengatasi hal tersebut dengan melakukan pertemuan dengan pihakpihak terkait seperti INSW (Indonesia National Single Window), Kemendag, SKK Migas, dan BeaCukai Pusat, pemeriksaan dokumen SPE secara berkala serta menjalin komunikasi yang baik antarpihak &#x0D; &#x0D; &#x0D;

Icaritin, a Novel Small-Molecule Immune Modulator in HBV-Related Refractory Advanced Hepatocellular Carcinoma: Safety, Immune Response, Durable Survival and Potential Predictive Biomarkers

Background: Despite the fact that approved kinase inhibitors and immune checkpoint inhibitors (ICIs) have improved overall survival (OS), a significant number of advanced hepatocellular carcinoma (HCC) patients have limited treatment options, particularly in developing countries. This phase II study aimed to explore the clinical efficacy of icaritin, a novel anti-inflammatory immune-modulatory small molecule, as potential oral administrative immunotherapy in HBV-related refractory advanced HCC patients. Methods: Major eligibility criteria included histologically confirmed unresectable advanced HCC with Child-Pugh class A or B liver function. Clinical endpoints included clinical efficacy and safety. Exploratory endpoints included immune biomarkers. Kaplan-Meier analysis was performed to correlate the immune response with OS and the associated biomarkers. Findings: No drug-related adverse events (AEs)≥grade III were observed in the enrolled cohort of 68 advanced HCC patients, 19 (28%) of whom were Child-Pugh class B and 62 (91.1%) of whom were hepatitis B virus positive(HBV+). The objective response evaluation showed cases of a partial response (PR) (1.7%), stable disease (SD) (32.8%) and progressive disease (PD) (59.0%), with a median overall survival (mOS) 254 days (95% CI, 172-296). The disease control rate (DCR) was 35.6% (95% CI, 22.7-47.7). Changes in the biomarkers IL-6, IL-8, IL-10, TNF-I±, TIM3, and LAG3 were significantly associated with OS. The mOS rates for the subgroups of HCC patients based on PD-L1 and IL-8 were 469 days (95%CI, 284-NA) and 475.5 days (95%CI, 309-NA), respectively. Whole-genome sequencing (WGS) analysis revealed that patients with high neoantigen levels or S. maltophilia positive showed a significant improvement in mOS. Interpretation: Icaritin demonstrated favorable clinical safety, an immune response based on a biomarker panel and associated with a significant improvement in durable survival. The potential biomarkers PD-L1, IL-8, neoantigen and S. maltophilia may predict the efficacy of icaritin treatment in HBV-related refractory advanced HCC patients. Clinical Trial Registration: Clinicaltrial.gov identifier: NCT01972672. Declaration of Interests: SQ, QL, J X, J L, Y C, J J, H Y7, HT; LZ, ZW; ZH, and YS declare no competing interests. SL is ex-employee and shareholder of Beijing Shenogen, BY, and KM are employees and shareholders of Beijing Shenogen Biomedical Ltd. Funding Statement: Beijing Shenogen Biomedical, Ltd. Ethical Approval Statement: All patients provided written informed consent before enrollment. The study was performed in accordance with good clinical practice and the Declaration of Helsinki guidelines. Approval from the appropriate ethics committees and institutional review boards was obtained and documented before the study. (Name of ethics committee: Cancer Hospital, Chinese Academy of Medical Sciences, National GCP Center for Anticancer Drugs; Ethic approval letter ID: 11-95/530, Clinical Protocol ID: TG11141CR; Approval date: Nov. 24, 2011).

Facilitating Learning Mathematics Through the Use of Instructional Media

The utilization of media to improve instructing and learning supplements conventional ways to deal with learning. Viable guidance fabricates between understudies’ information and the learning destinations in mathematics. Through the using of media, it engages students, aids them in knowledge retention, as well as motivates them. This study assessed the extent of instructional media utilization and the academic performance of the Grade 3 pupils in mathematics in a public elementary school, Cebu City, Philippines. The quantitative research method is being used in the study were data gathered through a variety of measurements treated, including the approval letter, parent’s consent, and the respondent’s survey checklist. The study revealed that teachers do not fully utilize the library and the audiovisual room of the school. It was concluded that the academic performance of the pupils are not based on how the teacher utilized the instructional media. The researchers recommend that the proposed enhancement plan be used and monitored.

Time to Viral Load Suppression and Its Associated Factors in Cohort of Patients Taking Antiretroviral Treatment in East Shewa Zone, Oromiya Region, Ethiopia, 2018

Background: Human immuno-deficiency virus (HIV) is a virus that causes Acquired ImmunoDeficiency Syndrome (AIDS). The key goal of ART is to achieve and maintain durable viral suppression. Thus, the most important use of the viral load is to monitor the effectiveness of therapy after initiation of ART. The main objective of the study was to determine the time for virological suppression and its associated factors among people living with HIV taking antiretroviral treatments in East Shewa zone, Oromiya, Ethiopia. Methods: The study was conducted in East Shewa zone, Oromiya, Ethiopia from August 2017 to January 2018. Patients diagnosed with human immunodeficiency virus presenting to the study health centers between October 3, 2011 and March 1, 2013 were included in the study given the following criteria: age 18 years or greater, eligible to start ART. All patients with baseline viral load measurement were included in the study. Interaction between explanatory variables with the response variable was analyzed by using cross tab features of SPSS, IBM Inc. Significance group comparison was done by Kaplan Meier log rank test. Cox proportional hazard model was used to select significant factors to the variability between groups. Data was collected by using structured questionnaires and interview. A total of ETB 81,120.00 was utilized to carry out the study. Result: plasma viral load was suppressed below detection level in 72% of individuals taking different regimen of ART. The median HIV-1 plasma viral load in the cohort was log 5.3111 copies/ml. Survival curve difference were observed in category of marital status (p-value 0.023) and baseline CD4 values (p-value 0.023) whereas no significant difference were observed in Educational status (p-value 0.404), MUAC (p- value 0.407) BMI(p-value 0.335) and BTB(pvalue 0.257). Estimated median time to PVL suppression was 181days (CI: 140.5-221.4) with the age group of 30-39years having minimum time to achieve suppression with 92 days (CI:60.1-123.8) and the maximum time required to reach the level was age group between 50-59 years. Conclusion: Estimated time to achieve Plasma Viral Load after taking ART was found to be 181 days. Factors affecting time to suppression level was marital status and baseline CD4. Funding: This research project is undertaken in partial fulfillment of the requirements for the degree of master's of public health in field epidemiology. All funding for the purpose of the project is covered St. Paul's hospital Millennium Medical College Department of Public Health. Declaration of Interests: The authors certify that we have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria, educational grants, participation in speakers' bureaus, membership, employment, consultancies, stock ownership or other equity interest, and expert testimony or patent-licensing arrangements), or non-financial intereest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript. Ethics Approval: Ethical approval was obtained from Saint Paul’s Hospital Millennium Medical college public health department ethical review committee. Then the approval letter was forwarded to Oromiya regional health beauro. Finally, the approval letter from regional health bureau submitted to Adama regional laboratory where the actual study was done. Study participants provided written informed consent. Informed consent were received from illiterate study participants in the previous study (35).

The duration of sleep in adolescent student in denpasar

Aim: To determine the duration of sleep of adolescents in high school in Denpasar. Material and Methods: A cross-sectional descriptive study, using a randomized sampling technique Performed in high school in Denpasar by the questionnaire-based survey. The inclusion criteria are adolescents of high school-aged 12-18 years agreed and signed a letter of approval as the subject of the study. Samples with medical disorders, psychiatric disorder, neurological disorders excluded. Research variables included: 1. Teen sleep duration in one day; 2. Variety of activities carried out by the subject both in & out school; 3. Sports habits; 4. Body Mass Index. Retrieving Data with the Pittsburgh Sleep Quality Index (PSQI), the Hamilton Halt Rating Scale (HARS) depression scale, obtained from the questionnaire the value of sleep duration and sleep quality index. Data were processed using SPSS 22. Results: 183 samples and 18 samples excluded because of medical illness. As many as 59.3% of women, the average age of 16.04 years, of which 54.5% sleep duration 8 hours with an average of 6-6.5 hours per day and started to sleep at 23.00 and 24.00, BMI 61,8% normal. The regular event of the subject is 1.72 hours per day outside the routine learning activities in the classroom, with the highest number of hours of exercise each day is 3 hours. Conclusion: The average sleep duration of adolescents in high schools in Denpasar is lacking and tends to prefer to sleep late at night.

Abortion as a Contested Right in Occupied Palestine

Abortion as a Contested Right in Occupied Palestine

Cumulative Trauma and Refugee Alcohol Misuse in Eritrean Refugees Living in Ethiopia: Structural Equation Modeling

Aim: This study was aimed at testing an established model, indicating co morbidity of alcohol misuse with psychological symptoms (PTSD and depression) and its association with cumulative trauma. Methods: In a cross-sectional survey, 562 adults were randomly selected from Eritrean refugees living in Mai Aini camp, Ethiopia. The Tigrigna versions of measures, namely: Pre and Post-Migration Living Difficulties checklist, Primary Care PTSD screener (PC-PTSD), Oslo Social Support Scale (OSS-3), Sense of Coherence Scale (SoC-13),Center for Epidemiologic Depression Scale (CES-D), Coping Style scale and Fast Alcohol Screening Test (FAST) were administered. Confirmatory Factor Analysis and structural equation modeling (SEM) were employed to test pre-specified models. Result: Alcohol misuse has significantly loaded onto the second-order common factor (β =0.21, p<0.001) with symptoms of PTSD and depression. Cumulative trauma is associated with this co morbid 'poor mental health' defining depression, PTSD and alcohol misuse both directly (β=0.76, p<0.001), and indirectly through psychological and social protective factors (indirect standardized coefficient=0.153, p=0.002) in a model which fitted to the current data [χ2/df =2.508, CFI=0.868; TLI=0.855, RMSEA= 0.052 (0.055 0.066)]. Conclusion: Cumulative trauma has directly and indirectly predicted poor mental health. Integrated assessment and intervention of alcohol misuse should be considered in refugee mental health care. Funding Statement: This study was financially supported by Addis Ababa University and University of Gondar, Ethiopia. Declaration of Interests: Authors declare that there is no conflict of interest. Ethics Approval Statement: This study was conducted after obtaining an ethical clearance from Institutional Ethical Review Board (IRB) of College of Health Sciences in Addis Ababa University (AAU) under approval letter (protocol number: 052/14/Psy). Indeed, Ethical issues as outlined by declaration of Helsinki for human participants in medical research were adhered.

Availability of Basic Radiographic Services at Governmental Hospitals-Gaza Governorates, Palestine

Background: The complex situation of the current health services exists to shift the system in significant ways to improve on this situation. The radiographic services need more efforts for building capacity. This study is conducted to evaluate radiographic services at governmental hospitals in Gaza Governorates. Methods: Triangulated study design was used for data collection. The quantitative part; 170 Radiologic Technologists completed questionnaires with 95.5% response rate. The researchers used arbitrated checklist to evaluate medical imaging facilities. Census study conducted on all Radiologic Technologists and medical imaging departments at six main governmental hospitals in the Gaza Strip. In addition, three key informant interviews with Radiologic Technologist managers were conducted. Findings: Findings revealed that shortage in number of radiographic equipment as well as Radiologic Technologists staff. The result reported statistically significant association between number of exams and patient waiting time in Conventional Radiography (p<0.001). Generally, radiographic departments that followed standard in structure were 45%. Regarding to fluoroscopic rooms, 79% of structure were followed the standard. The majority of existing Darkrooms full filled the international standard. Conclusion: An improvement in human resources among medical imaging facilities was clearly observed after 1996. An observable shortage in number of radiographic machines and Radiologic Technologists at all governmental hospitals. All departments revealed clear defect in structure, design and essential supplies. Critical readings were observed respecting to insufficient radiation protection tools and holding of Thermoluminescence Dosimeters. Funding: This research is supported by IBHATH program research grant from Qatar Charity to the Palestinian Researchers. Declaration of Interest: All authors declare that I have no significant competing financial, professional, or personal interests that might have influenced the performance or presentation of the work described in this manuscript. Ethics Approval Statement: An official letter of approval from the Helsinki committee in Gaza was obtained. Additionally, the official MOH directorates were formally contacted to obtain their approvals to conduct the study at MOH hospitals. Full explanatory form about research was attached to each questionnaire (the title of the study, purpose and other related information). The right to participate or not, confidentiality, anonymity of collected data were completely maintained and respected (Participants were signed informed consents as required).

ANALISIS PROSEDUR PENERBITAN SURAT PERSETUJUAN PENGELUARAN BARANG (SPPB) PADA KANTOR PENGAWASAN DAN PELAYANAN BEA DAN CUKAI TIPE MADYA PABEAN C MANADO

The one way to be able to control and supervise issuance of Approval Letter of Expenditure of Goods (SPPB) of import by carrying out the procedures and rules that apply. In the regulation of the Director General of Customs and Excise No. PER-16/BC/2016 concerning Hints Implementation Spending Goods Import For Used, explain about system work service Notice Import Goods (PIB) to on publishing Letter Approval Spending Goods (SPPB). Aim research this is for knowing procedure publishing Letter Objection Spending Goods (SPPB) on Oversight Office and Customs and Excise Type Madya Customs C Manado already corresponding or not yet corresponding with regulations director General of Customs and Excise No. PER-16 / BC / 2016. Research this use method research qualitatively. Results from research this that is procedure publishing Letter Approval Spending Goods (SPPB) already corresponding with rules director Jen deral Customs and Excise Number: PER -1 6 / BC / 2016. D iharapkan K antor Supervision and Customs and Excise Type Madya Customs C Manado continue improve quality in publishing Letter Approval Spending Goods (SPPB) imports, because now this so many goods imports coming in dae rah customs and need accuracy in p examination from stage importer fill and make Notice Import (PIB) to publishing Letter Approval Spending Goods (SPPB) so as not happen import prohibited goods sign in to in area customs and no reduce State revenue.Keywords : Procedures, rules, SPPB, import.

Selective Safety Data Collection in Clinical Studies of Oncology Drugs for Marketing Approval in the United States

Optimization of data collection is a key issue in clinical studies of oncology drugs because it affects the workload and financial burden of the clinical infrastructure. Focusing on oncology drugs, which produce many low-grade as well as serious adverse reactions, we investigated the use of selective safety data collection in the pivotal clinical studies for marketing approval in the United States. Drug labels were examined to find clinical studies that evaluated adverse events with limited data, and found ten drugs approved between 2004 and 2015 whose pivotal studies used selective rather than comprehensive safety data collection. Only three were in accordance with the 2001 FDA Guidance for Industry, "Cancer Drug and Biological Products -- Clinical Data in Marketing Applications", which suggests such selectivity when targeting a similar population to the initial approval. Two selective studies were applied to a drug's initial approval. Three adopted the Guidance criteria for safety data collection of only noting grade 4-5 hematologic and 3-5 non-hematologic toxicities.No major problems caused by this approach were found in the description of medical reviews, approval letters and post-marketing revisions to the boxed warnings on labels issued by the FDA. Selective safety data collection can be an efficient approach to streamlining the procedure of clinical studies and should be considered for use in pivotal clinical studies for oncology drugs.https://doi.org/10.21423/jrs-v05n02p036 (DOI assigned 3/11/2019)

HARMONISASI PENGATURAN TENTANG KEWENANGAN DALAM PENERBITAN SURAT PERSETUJUAN BERLAYAR (SPB) KAPAL IKAN DI PELABUHAN BELAWAN DITINJAU DARI UNDANG-UNDANG NOMOR 17 TAHUN 2008 TENTANG PELAYARAN DAN UNDANG-UNDANG NOMOR 45 TAHUN 2009 TENTANG PERIKANAN

Harmonization of regulations on competence (authority) in the Issuance Agreement Fish Sailing Ships in the Port of Belawan in terms of the Act.No. 17 of 2008 with the Act.No. 45 of 2009, particularly the provisions of Article 42 of Law. No. 45 of 2009 related to the authority of the harbor master in the issuance of the Letter of Approval Sailing, that disharmony (disharmony) legislation between Law. 17 of 2008 by Law.No. 45 of 2009, as well as including the rules below. Furthermore, the (legitimate) Letter of Approval issued by the harbor master Sailing Fishing in the port of Belawan, are legal under the law. No. 45 of 2009, but contrary to the Act. No. 12 Year 2011 on the Establishment of legislation is contrary to the principles of the law of the formation of law (the principle of legal drafting). Syahbandar legal responsibility in the fishing port was not entirely responsible for the accident because the fishing boats in the laws have not been set, but the laws of the cruise itself clearly and in detail to explain matters of ship wrecks including the inspection procedure shipwrecks.&lt;br /&gt;&lt;br /&gt;&lt;br /&gt;

Hand Held Technology; Its Place In a Environmental Compliance Monitoring System

This abstract will examine the elements of a field deployable inspection application designed to support the U S Environmental Protection Agency's (USEPA) field mission assignment, through the use of hand held technology. The system is designed to mimic a typical inspection through the use of software applications that replicate hard copy inspection forms. The primary elements of the program are in support of the Spill Prevention Control and Countermeasures (SPCC) regulations codified in Title 40 Code of Federal Regulations Part 112. These regulations govern prevention related activities, Facility Response Plans (FRPs) reviews and Government Initiated Unannounced Exercises (GIUEs). Accordingly, digital inspection/evaluation forms were created utilizing File Maker Pro development software. The forms have been deployed on Apple's IPAD tablets which allow for the integration of locational attributes of Google maps and the tablet's built in digital camera. A typical inspection will consist of an Administrative Form, Notice of Inspection (NOI), SPCC Inspection checklist, FRP Review checklist, FRP Field checklist, FRP Approval Letters and when applicable a GIUE evaluation forms. These files combine to form a complete inspection folder where it is either closed out as compliant or submitted to enforcement for further deliberation. A typical inspection begins with general inspection data being entered into the Administrative Form. Data entered here auto populates each corresponding inspection form. As an added enhancement, each inspection form can be pre- populated with consistently recorded values. This is generally the case when conducting multiple inspection where the company remains the same and/or the consultant has prepared plans in a uniform/standardized manner. Consequently, both latitudinal/longitudinal attributes are automatically embedded within the application along with photographic data. Upon completion of the inspection, the data is then synchronized with a GoZync Application with File Maker Pro server via WIFI or cellular connection. After file completion and administrative review, the report can be emailed to the recipient in a PDF format. To date, field trials have been completed on a local level with the expectation that Branch wide deployment will commence in late FY 16. The Agency recently made a nationwide buy of Apple tablets for On Scene Coordinators (OSCs) as well as inspection personnel within the response program. This helped pave the way for new application development and bringing to fruition the Agency's desired mission to perform its duties in a digital environment.

PP122 Strengthening Ethics Compliance In A Large Research Program: Uganda

INTRODUCTION:The infectious Diseases Institute (IDI) is a research institute at the College of Health Sciences, Makerere University. Over the years, the number of research studies has greatly increased with an average of fifty active studies per year. Because of the voluminous study activities, investigators were faced with inadvertences of ethical approval deadlines (1). In 2015, a centralized electronic Regulatory Affairs Information System (RAIS) was developed and piloted to track the regulatory process of the entire research projects. RAIS is a web-based system, developed using a Net framework and runs on any operating system using a web browser such as “Google Chrome” and “Mozilla Firefox”.METHODS:A signed approval letter from an accredited Research Ethics Committee, National Drug Authority and Uganda National Council of Science and Technology, the reviewed protocol, consent forms and data collection tools are uploaded electronically into the RAIS with study staff contact information, CVs and Good Clinical Practice (GCP) certificates. RAIS sends automatic “no reply” emails to the investigators and research administration notifying for the need of annual renewal 56, 28 and 14 days before the expiry date of the approvals. The investigator or designated person prepares the application package which is then forwarded to the Research Regulatory Officer for review and submission to the regulatory authority.RESULTS:From January 2015 to November 2016, fourty-three ongoing studies were uploaded to the RAIS of which eleven were clinical trials, twenty-one observational studies, seven diagnostic and four implementation studies. Studies that obtained their annual approvals before the expiry date was 90.7 percent, compared to 29 percent that had reported early submission for annual renewal between January 2013 and December 2014. RAIS has enabled continuity of study activities with timely annual renewed approvals, supported the tracking of staff GCP certificates and populated timely notifications to investigators, resulting in submission of annual application packages on time.CONCLUSIONS:RAIS has strengthened ethical regulatory compliance and provided an effective platform for tracking regulatory processes, thus enabled continuity of study activities with timely annual renewal approvals and greatly supported the tracking of staff GCP certificates.

Poster ‐ 28: Shielding of X‐ray Rooms in Ontario in the Absence of Best Practice

This poster will be strictly based on the Healing Arts Radiation Protection (HARP) Act, Regulation 543 under this Act (X‐ray Safety Code), and personal communication the presenting author has had. In Ontario, the process of approval of an X‐ray machine installation by the Director of the X‐ray Inspection Service (XRIS) follows a certain protocol. Initially, the applicant submits a series of forms, including recommended shielding amounts, in order to satisfy the law. This documentation is then transferred to a third‐party vendor (i.e. a professional engineer – P. Eng.) outsourced by the Ministry of Health and Long‐term Care (MOHLTC). The P.Eng. then evaluates the submitted documentation for appropriate fulfillment of the HARP Act and Reg. 543 requirements. If the P.Eng.'s evaluation of the documentation is to their satisfaction, the XRIS is then notified. Finally, the Director will then issue a letter of approval to install the equipment at the facility. The methodology required to be used by the P.Eng. in order to determine the required amounts of protective barriers, and recommended to be used by the applicant, is contained within Safety Code 20A. However, Safety Code 35 has replaced the obsolete Safety Code 20A document and employs best practices in shielding design. This talk will focus further on specific intentions and limitations of Safety Code 20A. Furthermore, this talk will discuss the definition of the “practice of professional engineering” in Ontario. COMP members who are involved in shielding design are strongly encouraged to attend.